MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS VANC REAGENT; IN-VITRO DIAGNOSTICS

Catalog Number	6801709
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from two different patient samples and a single level of non-vitros biorad liquichek immunoassay plus lot 1003930 control using vitros vancomycin (vanc) reagent lot 2514-57-3336 on a vitros xt 7600 integrated system.Patient sample 1 results of 9.23 ug/ml vs.The expected result of 16.35 ug/ml patient sample 2 result of 8.76 ug/ml vs.The expected result of 15.07 ug/ml biorad level 2 control results of 8.70 and 7.37 ug/ml vs.The baseline mean result of 16.47 ug/ml.The lower than expected vitros vanc patient sample results were reported outside of the laboratory, however, the results were questioned by the hospital pharmacy.Corrected reports were issued and there was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 613113.
Additional Manufacturer Narrative
The investigation has determined that lower than expected results were obtained from two different patient samples and a single level of non-vitros biorad liquichek immunoassay plus lot 1003930 control using vitros vancomycin (vanc) reagent lot 2514-57-3336 on a vitros xt 7600 integrated system.The assignable cause of the lower-than-expected results was a reagent pack related issue.The affected results were isolated to two different reagent packs.The issue with the affected reagent packs is unknown.The inventory of vitros vanc reagent lot 2514-57-3336 was depleted at the site and acceptable performance was obtained using an alternate reagent lot.Except for the affected reagent packs, there was no indication that vitros vanc reagent lot 2514-57-3336 was not performing as intended, based on historical quality control results.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros vanc reagent lot 2514-57-3336.Although no diagnostic within-run precision testing was performed to assess the performance of the vitros xt 7600 system, acceptable results were obtained from an alternate vitros vanc reagent lot without performing any actions to optimize the instrument.

• Brand Name: VITROS CHEMISTRY PRODUCTS VANC REAGENT
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24100941
• Report Number: 1319808-2026-00003
• Device Sequence Number: 21417833
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: (01)10758750006731(17)260322(11)250422(10)573336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2026
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-57-3336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown